MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE COMMAND; WIRE, GUIDE, CATHETER

Model Number	1013731
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a mildly calcified lesion in the anterior tibial artery.The ht command 18 guide wire was advanced through the sheath introducer and a crossing catheter was advanced.When re-loading the command guide wire, the black coating was noticed to be peeling off therefore the guide wire was not reused.Another command wire was used to continue the procedure without issue.There were no adverse patient effects reported and no clinically significant delays in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported peeled/delaminated was confirmed as material separation.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported peeled/delaminated appears to be related to the operational context of the procedure.It was reported that when re-loading the guide wire, peeling was noted on the wire.Analysis of the returned wire confirmed the peeling as polymer separation.The analysis also tears (chatter marks) on the polymer.This type of damage can occur when an accessory device interacts with the wire.Manipulation of the devices when an interaction occurs can result in polymer damage such as bunching, tearing, and separation.Additionally, bends were noted on the distal end of the wire.Damage sustained during use could contribute to interaction between the wire an accessory device.In this case, there is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20336293
• Report Number: 2024168-2024-11499
• Device Sequence Number: 7979353
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: (01)08717648212130(17)260531(10)4062961
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 1013731
• Device Catalogue Number: 1013731
• Device Lot Number: 4062961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSING CATHETER; INTRODUCER SHEATH
• Patient Sex: Unknown